1. Field of the Invention
The present invention relates to methods, compositions, and articles, effective for the prevention of HIV infection.
2. Discussion of the Background
Acquired immunodeficiency syndrome (AIDS) and AIDS related complex (ARC) are caused by infection with human immunodeficiency virus (HIV). Infection with HIV leads to AIDS in over 90% of infected individuals within a ten-year period. There is already a large number of individuals infected with HIV. Accordingly, the number of patients suffering from AIDS will continue to increase for the foreseeable future.
AZT (zidovudine) has received FDA approval for the treatment of AIDS and ARC. However, AZT can cause severe side effects, such as anemia. In addition, there are strains of HIV-1 which are resistant to treatment with AZT.
Cysteamine (2-aminoethanethiol) shows good in vitro activity against HIV. When added twice-daily to cultures of CEM-T.sub.4 lymphocytes, cysteamine at 100 .mu.M shows excellent protection against HTLVIII.sub.B with treated cells showing 133% of control survival, and no toxicity (120.8% of control) (Thoene, J., Clin. Res. Abstract, May, 1992)). Experiments on other cell lines and with other HIV strains substantiate the antiviral effect of cysteamine against HIV, and its lack of cellular toxicity at concentrations which completely inhibit the virus. Cystamine, the disulfide of cysteamine, also demonstrates substantial activity against the HIV pathogen, and shows little cytotoxicity at 100 .mu.M concentration.
Preventing sexual transmission of the AIDS pathogen is at least as important to the public health as is finding a cure for AIDS. Recent reports which raise doubts about the efficacy of AZT have reinforced the need for agents which reduce or prevent person-to-person spread of HIV. This finding was emphasized in a review of the Berlin IX International AIDS conference, in which Michael Merson, head of the World Health Organization's Global Program on AIDS, was reported to have " . . . implored scientists to develop a vaginal microbicide that could defeat HIV and other pathogens . . . " (Cohen, Jon, Science, vol. 260, 1712-1713 (1993)).
Thus, although a number of antiviral agents have been identified for the treatment of AIDS, to date, no effective agents for the prophylaxis of HIV infection are available. Thus, there remains a need for methods and compositions which are effective for the prevention of HIV infection.